ClinPhone has launched a new web-based service that for the first time allows companies sponsoring clinical trials to manage the entire supply chain, from manufacture of the drug under test right through to the destruction of unwanted materials.
The service – the first of its type on the market, according to ClinPhone – provides clinical trial sponsors with a means to ensure they meet regulatory requirements to track investigational drugs from manufacture to destruction. The electronic solution was showcased to the industry for the first time at this week’s Drug Information Association meeting in Philadelphia, USA.
Current systems using interactive voice recognition (IVR) are already very good at managing part of the supply chain – coordinating the shipment of drug to study sites, and allocating packs to patients – but that is as far as they go. Trial sponsors need to physically dispense medication to patients, and receive packs back from patients at their next visit to count tablets used, as well as record all that information and then ship the unused drug off to be destroyed.
At the end of a study, a sponsor has to be able to show regulators the complete lifecycle of a pack and, while it is difficult to gauge just how many trials fall short on this point, the number of warning letters sent out by the US Food and Drug Administration is ‘quite significant’, according to Nikki Dowlman, product development specialist at ClinPhone.
The consequences of non-compliance can potentially be quite serious, she told Pharma Times, ranging from a caution through to regulators asking that clinical investigators no longer take part n trials, or indeed that the data generated in a trial is no longer valid.
Bill Byrom, director of product strategy at ClinPhone, said the company’s clients are very aware that the current methods of collecting drug accountability and reconciliation data are ‘problematic’.
“They involve numerous sources of information that need to be consolidated to prove the lifecycle for every pack”, he said. “In reality this is a very difficult activity for them, involving depot records, site records, destruction records etc all have to be pulled together, and having this centrally done by an electronic solution is a big step forward.”
Roche’s Michael Grabo, a specialist in clinical supply, welcomes the availability of an electronic solution that can cut out some of the legwork in the drug accountability and reconciliation process.
These are “painful activities where the site and monitoring personnel really bear the brunt of the manual process,” he commented. “The largely paper-based documentation, which is often disparate and duplicate, means people spend many frustrating hours accounting for and reconciling investigational drugs throughout the duration of the trial.”
The paper-based process is not only labour-intensive and time-consuming, but also open to errors, according to Dowlman, who also noted that the software can free up trial monitors’ time, allowing them to spend less on reconciliation actions and more on other tasks, including looking at patient records.
It can also be used to make sure that production of clinical trial materials is being carried out efficiently, preventing overage by providing precise information about the volume of drug that was never received by the patient, or expired before use, she said. The drug accountability software can provide a simulation to guide production for subsequent studies and reduce waste, which could be of particular value when dealing with complex medicines, such as certain biologics, that can be expensive to manufacture.
Byrom noted the product is currently being sold alongside ClinPhone’s IVR services for stocking study sites and allocating medicines to patients. “It’s a hosted service that operates as an add-on to our existing IVR services,” he said.